Moist oral compositions

ABSTRACT

The disclosure provides for an oral composition, the oral composition including at least one active agent, at least one filler component, and water in an amount sufficient such that the oral composition has a total moisture content of about 15% to about 30% by weight or greater based on the total weight of the oral composition.

FIELD OF THE DISCLOSURE

The present disclosure relates to flavored products intended for humanuse. The products are configured for oral use and deliver substancessuch as flavors and/or active ingredients during use. Such products mayinclude tobacco or a product derived from tobacco, or may betobacco-free alternatives.

BACKGROUND

Tobacco may be enjoyed in a so-called “smokeless” form. Particularlypopular smokeless tobacco products are employed by inserting some formof processed tobacco or tobacco-containing formulation into the mouth ofthe user. Conventional formats for such smokeless tobacco productsinclude moist snuff, snus, and chewing tobacco, which are typicallyformed almost entirely of particulate, granular, or shredded tobacco,and which are either portioned by the user or presented to the user inindividual portions, such as in single-use pouches or sachets. Othertraditional forms of smokeless products include compressed oragglomerated forms, such as plugs, tablets, or pellets. Alternativeproduct formats, such as tobacco-containing gums and mixtures of tobaccowith other plant materials, are also known. See for example, the typesof smokeless tobacco formulations, ingredients, and processingmethodologies set forth in U.S. Pat. No. 1,376,586 to Schwartz; U.S.Pat. No. 4,513,756 to Pittman et al.; U.S. Pat. No. 4,528,993 toSensabaugh, Jr. et al.; U.S. Pat. No. 4,624,269 to Story et al.; U.S.Pat. No. 4,991,599 to Tibbetts; U.S. Pat. No. 4,987,907 to Townsend;U.S. Pat. No. 5,092,352 to Sprinkle, III et al.; U.S. Pat. No. 5,387,416to White et al.; U.S. Pat. No. 6,668,839 to Williams; U.S. Pat. No.6,834,654 to Williams; U.S. Pat. No. 6,953,040 to Atchley et al.; U.S.Pat. No. 7,032,601 to Atchley et al.; and U.S. Pat. No. 7,694,686 toAtchley et al.; U.S. pat. pub. Nos. 2004/0020503 to Williams;2005/0115580 to Quinter et al.; 2006/0191548 to Strickland et al.;2007/0062549 to Holton, Jr. et al.; 2007/0186941 to Holton, Jr. et al.;2007/0186942 to Strickland et al.; 2008/0029110 to Dube et al.;2008/0029116 to Robinson et al.; 2008/0173317 to Robinson et al.;2008/0209586 to Neilsen et al.; 2009/0065013 to Essen et al.; and2010/0282267 to Atchley, as well as WO2004/095959 to Arnarp et al., eachof which is incorporated herein by reference.

Smokeless tobacco product configurations that combine tobacco materialwith various binders and fillers have been proposed more recently, withexample product formats including lozenges, pastilles, gels, extrudedforms, and the like. See, for example, the types of products describedin U.S. patent app. Pub. Nos. 2008/0196730 to Engstrom et al.;2008/0305216 to Crawford et al.; 2009/0293889 to Kumar et al.;2010/0291245 to Gao et al; 2011/0139164 to Mua et al.; 2012/0037175 toCantrell et al.; 2012/0055494 to Hunt et al.; 2012/0138073 to Cantrellet al.; 2012/0138074 to Cantrell et al.; 2013/0074855 to Holton, Jr.;2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 toJackson et al.; 2015/0068545 to Moldoveanu et al.; 2015/0101627 toMarshall et al.; and 2015/0230515 to Lampe et al., each of which isincorporated herein by reference.

All-white snus portions are growing in popularity, and offer a discreteand aesthetically pleasing alternative to traditional snus. Such modern“white” pouched products may include a bleached tobacco or may betobacco-free. Products of this type may suffer from certain drawbacks,such as poor product stability that could lead to discoloration of theproduct and/or undesirable organoleptic characteristics.

BRIEF SUMMARY

The present disclosure generally provides compositions and productsconfigured for oral use. The products may be configured to impart ataste when used orally and, additionally or alternatively, may deliveractive ingredients to a consumer, such as nicotine. The products andmethods of the present disclosure in particular may be adapted orconfigured to provide one or more materials to a consumer at acontrolled release rate, such as a sustained release.

In one or more embodiments, the present disclosure particularly canprovide oral compositions including an active ingredient and a desiredwater content. For example, useful compositions can comprise at leastone active agent, at least one filler component, and water in an amountsufficient such that the oral composition has a total moisture contentof about 15% to about 30% by weight or greater based on the total weightof the oral composition.

The disclosure includes, without limitations, the following embodiments.

Embodiment 1: An oral composition comprising at least one active agent,at least one filler component, and water in an amount sufficient suchthat the oral composition has a total moisture content of about 15% toabout 30% by weight or greater based on the total weight of the oralcomposition.

Embodiment 2: The oral composition of embodiment 1, wherein at least aportion of the at least one active agent may be bound to at least aportion of the at least one filler component.

Embodiment 3: The oral composition of any one of embodiments 1 to 2,wherein the oral composition may further comprise a binding agent.

Embodiment 4: The oral composition of any one of embodiments 1 to 3,wherein, the binding agent may be selected from a group consisting ofpovidone, sodium alginate, starch-based binders, pectin, carrageenan,pullulan, zein, gum, and combinations thereof.

Embodiment 5: The oral composition of any one of embodiments 1 to 4,wherein the at least one active agent may be selected from a groupconsisting of botanicals, stimulants, amino acids, vitamins,cannabinoids, cannabimimetics, terpenes, nutraceuticals, andcombinations thereof.

Embodiment 6: The oral composition of any one of embodiments 1 to 5,wherein the at least one active agent may be a nicotine component.

Embodiment 7: The oral composition of any one of embodiments 1 to 6,wherein, the nicotine component may be one or both of nicotine free baseand a nicotine salt.

Embodiment 8: The oral composition of any one of embodiments 1 to 7,wherein the nicotine component may be present in an amount such that aweight to weight ratio of the nicotine component to the total moisturecontent is substantially low, such as about 0.01 to about 0.2, about0.02 to about 0.1, or about 0.03 to about 0.08.

Embodiment 9: The oral composition of any one of embodiments 1 to 8,wherein the nicotine component may be present in an amount of greaterthan 2% by weight based on the total weight of the oral composition.

Embodiment 10: The oral composition of any one of embodiments 1 to 9,wherein the nicotine component may be present in an amount of about 3%to about 10% by weight based on the total weight of the oralcomposition.

Embodiment 11: The oral composition of any one of embodiments 1 to 10,wherein, the water may be present in an amount such that oralcomposition has a total moisture content of greater than 20% by weightbased on the total weight of the oral composition.

Embodiment 12: The oral composition of any one of embodiments 1 to 1wherein the water may be present in an amount such that oral compositionhas a total moisture content of about 20% to about 45% by weight basedon the total weight of the oral composition.

Embodiment 13: The oral composition of any one of embodiments 1 to 12,wherein the oral composition may be substantially or completely free oftobacco.

Embodiment 14: The oral composition of any one of embodiments 1 to 13,wherein the oral composition may have a pH that is greater than 7.

Embodiment 15: The oral composition of any one of embodiments 1 to 14,wherein the nicotine component may be present in an amount of less than1% by weight based on the total weight of the oral composition.

Embodiment 16: The oral composition of any one of embodiments 1 to 15,wherein the nicotine component may be present in an amount of about0.01% to about 0.9% by weight based on the total weight of the oralcomposition.

Embodiment 17: The oral composition of any one of embodiments 1 to 16,wherein the water may be present in an amount such that oral compositionhas a total moisture content of about 15% to about 30% by weight basedon the total weight of the oral composition.

Embodiment 18: The oral composition of any one of embodiments 1 to 17,wherein the composition may further comprise a cyclodextrin.

Embodiment 19: The oral composition of any one of embodiments 1 to 18,wherein at least a portion of the at least one active agent may be boundto the cyclodextrin.

Embodiment 20: The oral composition of any one of embodiments 1 to 19,wherein the water may be present in an amount such that oral compositionhas a total moisture content of about 15% to about 30% by weight basedon the total weight of the oral composition.

Embodiment 21: The oral composition of any one of embodiments 1 to 20,wherein the oral composition may be positioned within a pouch.

Embodiment 22: The oral composition of any one of embodiments 1 to 21,wherein the oral composition may comprise a white tobacco material in atleast a trace amount but in an amount less than 10% by weight, excludingany nicotine component present in the oral composition, based on thetotal weight of the oral composition.

These and other features, aspects, and advantages of the disclosure willbe apparent from a reading of the following detailed descriptiontogether with the accompanying drawings, which are briefly describedbelow. The invention includes any combination of two, three, four, ormore of the above-noted embodiments as well as combinations of any two,three, four, or more features or elements set forth in this disclosure,regardless of whether such features or elements are expressly combinedin a specific embodiment description herein. This disclosure is intendedto be read holistically such that any separable features or elements ofthe disclosed invention, in any of its various aspects and embodiments,should be viewed as intended to be combinable unless the context clearlydictates otherwise.

BRIEF DESCRIPTION OF THE DRAWING

Having thus described aspects of the disclosure in the foregoing generalterms, reference will now be made to the accompanying drawing, which isnot necessarily drawn to scale. The drawing is exemplary only, andshould not be construed as limiting the disclosure.

The FIGURE is a perspective view of a pouched product according to anexample embodiment of the present disclosure including a pouch or fleeceat least partially filled with a composition for oral use.

DETAILED DESCRIPTION

The present disclosure provides compositions and products formedtherefrom, the compositions and products particularly being configuredfor oral use. The compositions and products may incorporate one or moreactive agents and one or more filler components. The compositions andproducts likewise can provide a desired sensory property in the mouth ofa consumer, such as providing a feeling of moistness, and thecompositions and products thus can include at least a minimum content ofwater or other moistening agent.

The present disclosure will now be described more fully hereinafter withreference to example embodiments thereof. These example embodiments aredescribed so that this disclosure will be thorough and complete, andwill fully convey the scope of the disclosure to those skilled in theart. Indeed, the disclosure may be embodied in many different forms andshould not be construed as limited to the embodiments set forth herein;rather, these embodiments are provided so that this disclosure willsatisfy applicable legal requirements. As used in this specification andthe claims, the singular forms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise. Reference to“dry weight percent” or “dry weight basis” refers to weight on the basisof dry ingredients (i.e., all ingredients except water). Reference to“wet weight” refers to the weight of the mixture including water. Unlessotherwise indicated, reference to “weight percent” of a mixture reflectsthe total wet weight of the mixture (i.e., including water).

The present disclosure provides a composition that may be included inproducts. More particularly, in some embodiments, the disclosureprovides for oral compositions including at least one active agent, atleast one filler component, and water. The water preferably can bepresent in an amount sufficient such that the oral composition has atotal moisture content of about 15% by weight or greater based on thetotal weight of the oral composition. As described, the compositions maybe provided in a variety of forms and, as further described herein,specifically, may be provided in a substantially solid form, such as acollection of particles, fibers, or the like. Accordingly, a product mayinclude the composition itself, or the composition positioned within aunitizing structure, such as a pouch, a fleece, or the like. In someembodiments, the products as described herein comprise a mixture ofcomponents, typically including at least one carrier and/or filler andat least one flavoring agent and/or active ingredient. In someembodiments, the composition further comprises one or more salts, one ormore sweeteners, one or more binding agents, one or more humectants, oneor more gums, an organic acid, a tobacco material, a tobacco-derivedmaterial, or a combination thereof. The relative amounts of the variouscomponents within the composition may vary, and typically are selectedso as to provide the desired sensory and performance characteristics tothe oral product. The example individual components of the compositionare described herein below.

Carrier Filler Component

Compositions as described herein include at least one component that maybe characterized as being a carrier component and/or a filler component.In some embodiments, the compositions may include both of a carrier anda filler, and various materials may fulfill the function of both acarrier and a filler. A carrier component according to the presentdisclosure preferably may be adapted to or configured to retain at leasta flavor component and/or an active agent as described herein and may,in some embodiments, retain substantially all of the further componentsof the composition. A filler component may fulfill multiple functions,such as enhancing certain organoleptic properties such as texture andmouthfeel, enhancing cohesiveness or compressibility of the product, andthe like. Generally, the filler components are porous particulatematerials. In some embodiments, the present compositions may comprise acarrier. In further embodiments, the present compositions may comprise acarrier and a filler.

In some embodiments, a carrier component and/or a filler component maybe cellulose-based. For example, suitable particulate components are anynon-tobacco plant material or derivative thereof, including cellulosematerials derived from such sources. Examples of cellulosic non-tobaccoplant material include cereal grains (e.g., maize, oat, barley, rye,buckwheat, and the like), sugar beet (e.g., FIBREX® brand filleravailable from International Fiber Corporation), bran fiber, andmixtures thereof. Non-limiting examples of derivatives of non-tobaccoplant material include starches (e.g., from potato, wheat, rice, corn),natural cellulose, and modified cellulosic materials. Additionalexamples of potential particulate carrier and/or filler componentsinclude maltodextrin, dextrose, calcium carbonate, calcium phosphate,lactose, mannitol, xylitol, and sorbitol. Combinations of materials canalso be used.

“Starch” as used herein may refer to pure starch from any source,modified starch, or starch derivatives. Starch is present, typically ingranular form, in almost all green plants and in various types of planttissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers,shoots, fruits, grains, and stems). Starch can vary in composition, aswell as in granular shape and size. Often, starch from different sourceshas different chemical and physical characteristics. A specific starchcan be selected for inclusion in the mixture based on the ability of thestarch material to impart a specific organoleptic property tocomposition. Starches derived from various sources can be used. Forexample, major sources of starch include cereal grains (e.g., rice,wheat, and maize) and root vegetables (e.g., potatoes and cassava).Other examples of sources of starch include acorns, arrowroot,arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans,peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia,katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago,sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, waterchestnuts, and yams. Certain starches are modified starches. A modifiedstarch has undergone one or more structural modifications, oftendesigned to alter its high heat properties. Some starches have beendeveloped by genetic modifications, and are considered to be“genetically modified” starches. Other starches are obtained andsubsequently modified by chemical, enzymatic, or physical means. Forexample, modified starches can be starches that have been subjected tochemical reactions, such as esterification, etherification, oxidation,depolymerization (thinning) by acid catalysis or oxidation in thepresence of base, bleaching, transglycosylation and depolymerization(e.g., dextrinization in the presence of a catalyst), cross-linking,acetylation, hydroxypropylation, and/or partial hydrolysis. Enzymatictreatment includes subjecting native starches to enzyme isolates orconcentrates, microbial enzymes, and/or enzymes native to plantmaterials, e.g., amylase present in corn kernels to modify corn starch.Other starches are modified by heat treatments, such aspregelatinization, dextrinization, and/or cold water swelling processes.Certain modified starches include monostarch phosphate, distarchglycerol, distarch phosphate esterified with sodium trimetaphosphate,phosphate distarch phosphate, acetylated distarch phosphate, starchacetate esterified with acetic anhydride, starch acetate esterified withvinyl acetate, acetylated distarch adipate, acetylated distarchglycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, starchsodium octenyl succinate.

In some embodiments, a carrier component and/or a filler component maybe a cellulose material or cellulose derivative. One particularlysuitable material for use in the products described herein ismicrocrystalline cellulose (“MCC”). The MCC may be synthetic orsemi-synthetic, or it may be obtained entirely from natural celluloses.The MCC may be selected from the group consisting of AVICEL® gradesPH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302,VIVACEL® grades 101, 102, 12, 20 and EMOCEL® grades 50M and 90M, and thelike, and mixtures thereof. In one embodiment, a composition asdescribed herein may comprise MCC as a particulate filler componentand/or as a carrier component. The quantity of MCC present in thecompositions as described herein may vary according to the desiredproperties. In some embodiments, a cellulose derivative or a combinationof such derivatives in particular may be used in combination with adifferent carrier component, and this particularly can include cellulosederivatives, such as a cellulose ether (including carboxyalkyl ethers),meaning a cellulose polymer with the hydrogen of one or more hydroxylgroups in the cellulose structure replaced with an alkyl, hydroxyalkyl,or aryl group. Non-limiting examples of such cellulose derivativesinclude methylcellulose, hydroxypropylcellulose (“HPC”),hydroxypropylmethylcellulose (“HPMC”), hydroxyethyl cellulose, andcarboxymethylcellulose (“CMC”). In one embodiment, the cellulosederivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC.

The total amount of carrier component(s) and filler component(s) presentin the composition can vary, but is typically up to about 75 percent ofthe composition by weight, based on the total weight of the composition.A typical range of total carrier and/or filler component within thecomposition can be from about 10 to about 75 percent by total weight ofthe composition, for example, from about 10, about 15, about 20, about25, or about 30, to about 35, about 40, about 45, or about 50 weightpercent (e.g., about 20 to about 50 weight percent or about 25 to about45 weight percent). In certain embodiments, the total amount ofcarrier/filler component is at least about 10 percent by weight, such asat least about 20 percent, or at least about 25 percent, or at leastabout 30 percent, or at least about 35 percent, or at least about 40percent, based on the total weight of the composition.

In one or more embodiments, a carrier component may be adapted to orconfigured to substantially surround or envelop further components ofthe composition. For example, the carrier may be configured as a packet,a pouch, a fleece, or the like, and such structures are furtherdescribed herein. The term “fleece” may particularly be used herein as acommon term for such structures and should not be viewed as limiting thenature of the structure.

A suitable fleece, for example, may be formed of a plurality of fibers.The term “fiber” as used herein includes both fibers of finite length,such as conventional staple fibers and nanofibers, as well assubstantially continuous structures, such as continuous filaments,unless otherwise indicated. The fibers can have a substantially round orcircular cross section or non-circular cross sections (for example,oval, rectangular, multi-lobed, and the like). The fibers can beprovided in a variety of configurations, and the fibers particularly caninclude multicomponent fibers.

In some embodiments, the fleece can be in the form of a non-wovenmaterial. The term “nonwoven” is used herein in reference to fibrousmaterials, webs, mats, batts, or sheets in which fibers are aligned inan undefined or random orientation. In some embodiments, the pluralityof fibers used in forming a fleece may include heat sealable and/ormeltable binder fibers. Further aspects of a suitable pouch or fleeceare further described below.

Active Ingredients

In some embodiments the present compositions and products may compriseat least one active ingredient or agent. As used herein, an “activeingredient” refers to one or more substances belonging to any of thefollowing categories: API (active pharmaceutical ingredient), foodadditives, natural medicaments, and naturally occurring substances thatcan have an effect on humans. Example active ingredients include anyingredient known to impact one or more biological functions within thebody, such as ingredients that furnish pharmacological activity or otherdirect effect in the diagnosis, cure, mitigation, treatment, orprevention of disease, or which affect the structure or any function ofthe body of humans (e.g., provide a stimulating action on the centralnervous system, have an energizing effect, an antipyretic or analgesicaction, or an otherwise useful effect on the body). In some embodiments,the active ingredient may be of the type generally referred to asdietary supplements, nutraceuticals, “phytochemicals” or “functionalfoods.” These types of additives are sometimes defined in the art asencompassing substances typically available from naturally-occurringsources (e.g., botanical materials) that provide one or moreadvantageous biological effects (e.g., health promotion, diseaseprevention, or other medicinal properties), but are not classified orregulated as drugs. For example, the compositions and products mayinclude a single active ingredient or a plurality of active ingredients.If desired, at least one active ingredient may be retained on at least aportion of the at least one filler component, and one or more activeingredients may be otherwise retained in the compositions and/orproducts, such as being bound to a further filler or being present in aunitary form (e.g., pelletized active ingredients).

Non-limiting examples of active ingredients include those falling in thecategories of botanical ingredients, stimulants, amino acids, nicotinecomponents, and/or pharmaceutical, nutraceutical, and medicinalingredients (e.g., vitamins, such as A, B3, B6, B12, and C, and/orcannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)).Each of these categories is further described herein below. Theparticular choice of active ingredients will vary depending upon thedesired flavor, texture, and desired characteristics of the particularproduct.

In certain embodiments, the active ingredient is selected from the groupconsisting of caffeine, taurine, GABA, theanine, vitamin C, B vitamins(e.g., vitamin B6 or B12), lemon balm extract, tryptophan, ginseng,citicoline, sunflower lecithin, and combinations thereof. For example,the active ingredient can include a combination of caffeine, theanine,and optionally ginseng. In another embodiment, the active ingredientincludes a combination of theanine, gamma-amino butyric acid (GABA), andlemon balm extract. In a further embodiment, the active ingredientincludes theanine, theanine and tryptophan, or theanine and one or moreB vitamins (e.g., vitamin B6 or B12). In a still further embodiment, theactive ingredient includes a combination of caffeine, taurine, andvitamin C.

The particular percentages of active ingredients present will varydepending upon the desired characteristics of the particular product.Typically, an active ingredient or combination thereof is present in atotal concentration of at least about 0.001% by weight of thecomposition, such as in a range from about 0.001% to about 20%. In someembodiments, the active ingredient or combination of active ingredientsis present in a concentration from about 0.1% w/w to about 10% byweight, such as, e.g., from about 0.5% w/w to about 10%, from about 1%to about 10%, from about 1% to about 5% by weight, based on the totalweight of the composition. In some embodiments, the active ingredient orcombination of active ingredients is present in a concentration of fromabout 0.001%, about 0.01%, about 0.1%, or about 1%, up to about 20% byweight, such as, e.g., from about 0.001%, about 0.002%, about 0.003%,about 0.004%, about 0.005%, about 0.006%, about 0.007%, about 0.008%,about 0.009%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%,about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%,about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%,about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%,about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about18%, about 19%, or about 20% by weight, based on the total weight of thecomposition. Further suitable ranges for specific active ingredients areprovided herein below.

Botanical

In some embodiments, the active ingredient comprises a botanicalingredient. As used herein, the term “botanical ingredient” or“botanical” refers to any plant material or fungal-derived material,including plant material in its natural form and plant material derivedfrom natural plant materials, such as extracts or isolates from plantmaterials or treated plant materials (e.g., plant materials subjected toheat treatment, fermentation, bleaching, or other treatment processescapable of altering the physical and/or chemical nature of thematerial). For the purposes of the present disclosure, a “botanical”includes, but is not limited to, “herbal materials,” which refer toseed-producing plants that do not develop persistent woody tissue andare often valued for their medicinal or sensory characteristics (e.g.,teas or tisanes). Reference to botanical material as “non-tobacco” isintended to exclude tobacco materials (i.e., does not include anyNicotiana species). In some embodiments, the compositions as disclosedherein can be characterized as free of any tobacco material (e.g., anyembodiment as disclosed herein may be completely or substantially freeof any tobacco material). By “substantially free” is meant that notobacco material has been intentionally added. For example, certainembodiments can be characterized as having less than 0.001% by weight oftobacco, or less than 0.0001%, or even 0% by weight of tobacco.

When present, a botanical is typically at a concentration of from about0.01% w/w to about 10% by weight, such as, e.g., from about 0.01% w/w,about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight,based on the total weight of the composition.

The botanical materials useful in the present disclosure may comprise,without limitation, any of the compounds and sources set forth herein,including mixtures thereof. Certain botanical materials of this type aresometimes referred to as dietary supplements, nutraceuticals,“phytochemicals” or “functional foods.” Certain botanicals, as the plantmaterial or an extract thereof, have found use in traditional herbalmedicine, and are described further herein. Non-limiting examples ofbotanicals or botanical-derived materials include ashwagandha, Bacopamonniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherryblossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps,curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essentialoils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba,ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia,guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thaiginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein,maca, matcha, Nardostachys chinensis, oil-based extract of Violaodorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae,Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum,Schisandra, Skullcap, spearmint extract, Spikenard, terpenes, tisanes,turmeric, Turnera aphrodisiaca, valerian, white mulberry, and Yerbamate.

In some embodiments, the active ingredient comprises lemon balm. Lemonbalm (Melissa officinalis) is a mildly lemon-scented herb from the samefamily as mint (Lamiaceae). The herb is native to Europe, North Africa,and West Asia. The tea of lemon balm, as well as the essential oil andthe extract, are used in traditional and alternative medicine. In someembodiments, the active ingredient comprises lemon balm extract. In someembodiments, the lemon balm extract is present in an amount of fromabout 1 to about 4% by weight, based on the total weight of thecomposition.

In some embodiments, the active ingredient comprises ginseng. Ginseng isthe root of plants of the genus Panax, which are characterized by thepresence of unique steroid saponin phytochemicals (ginsenosides) andgintonin. Ginseng finds use as a dietary supplement in energy drinks orherbal teas, and in traditional medicine. Cultivated species includeKorean ginseng (P. ginseng), South China ginseng (P. notoginseng), andAmerican ginseng (P. quinquefolius). American ginseng and Korean ginsengvary in the type and quantity of various ginsenosides present. In someembodiments, the ginseng is American ginseng or Korean ginseng. Inspecific embodiments, the active ingredient comprises Korean ginseng. Insome embodiments, ginseng is present in an amount of from about 0.4 toabout 0.6% by weight, based on the total weight of the composition.

Stimulants

In some embodiments, the active ingredient comprises one or morestimulants. As used herein, the term “stimulant” refers to a materialthat increases activity of the central nervous system and/or the body,for example, enhancing focus, cognition, vigor, mood, alertness, and thelike. Non-limiting examples of stimulants include caffeine, theacrine,theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid)is apurine alkaloid which is structurally related to caffeine, andpossesses stimulant, analgesic, and anti-inflammatory effects. Presentstimulants may be natural, naturally derived, or wholly synthetic. Forexample, certain botanical materials (guarana, tea, coffee, cocoa, andthe like) may possess a stimulant effect by virtue of the presence ofe.g., caffeine or related alkaloids, and accordingly are “natural”stimulants. By “naturally derived” is meant the stimulant (e.g.,caffeine, theacrine) is in a purified form, outside its natural (e.g.,botanical) matrix. For example, caffeine can be obtained by extractionand purification from botanical sources (e.g., tea). By “whollysynthetic”, it is meant that the stimulant has been obtained by chemicalsynthesis. In some embodiments, the active ingredient comprisescaffeine. In some embodiments, the caffeine is present in anencapsulated form. On example of an encapsulated caffeine is Vitashure®,available from Balchem Corp., 52 Sunrise Park Road, New Hampton, N.Y.,10958.

When present, a stimulant or combination of stimulants (e.g., caffeine,theacrine, and combinations thereof) is typically at a concentration offrom about 0.1% w/w to about 15% by weight, such as, e.g., from about0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 11%, about 12%, about 13%, about 14%, or about 15% by weight,based on the total weight of the composition. In some embodiments, thecomposition comprises caffeine in an amount of from about 1.5 to about6% by weight, based on the total weight of the composition;

Amino Acids

In some embodiments, the active ingredient comprises an amino acid. Asused herein, the term “amino acid” refers to an organic compound thatcontains amine (—NH₂) and carboxyl (—COOH) or sulfonic acid (SO₃H)functional groups, along with a side chain (R group), which is specificto each amino acid. Amino acids may be proteinogenic ornon-proteinogenic. By “proteinogenic” is meant that the amino acid isone of the twenty naturally occurring amino acids found in proteins. Theproteinogenic amino acids include alanine, arginine, asparagine,aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine,isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine,threonine, tryptophan, tyrosine, and valine. By “non-proteinogenic” ismeant that either the amino acid is not found naturally in protein, oris not directly produced by cellular machinery (e.g., is the product ofpost-translational modification). Non-limiting examples ofnon-proteinogenic amino acids include gamma-aminobutyric acid (GABA),taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide),hydroxyproline, and beta-alanine. In some embodiments, the activeingredient comprises theanine. In some embodiments, the activeingredient comprises GABA. In some embodiments, the active ingredientcomprises a combination of theanine and GABA. In some embodiments, theactive ingredient is a combination of theanine, GABA, and lemon balm. Insome embodiments, the active ingredient is a combination of caffeine,theanine, and ginseng. In some embodiments, the active ingredientcomprises taurine. In some embodiments, the active ingredient is acombination of caffeine and taurine.

When present, an amino acid or combination of amino acids (e.g.,theanine, GABA, and combinations thereof) is typically at aconcentration of from about 0.1% w/w to about 15% by weight, such as,e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%,about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%,about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, orabout 15% by weight, based on the total weight of the composition.

Vitamins

In some embodiments, the active ingredient comprises a vitamin orcombination of vitamins. As used herein, the term “vitamin” refers to anorganic molecule (or related set of molecules) that is an essentialmicronutrient needed for the proper functioning of metabolism in amammal. There are thirteen vitamins required by human metabolism, whichare: vitamin A (as all-trans-retinol, all-trans-retinyl-esters, as wellas all-trans-beta-carotene and other provitamin A carotenoids), vitaminB1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5(pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin),vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C(ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols andtocotrienols), and vitamin K (quinones). In some embodiments, the activeingredient comprises vitamin C. In some embodiments, the activeingredient is a combination of vitamin C, caffeine, and taurine.

When present, a vitamin or combination of vitamins (e.g., vitamin B6,vitamin B12, vitamin E, vitamin C, or a combination thereof) istypically at a concentration of from about 0.01% w/w to about 6% byweight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,or about 0.1% w/w, to about 0.2%, about 0.3%, about 0.4%, about 0.5%about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%,about 3%, about 4%, about 5% or about 6% by weight, based on the totalweight of the composition.

Antioxidants

In some embodiments, the active ingredient comprises one or moreantioxidants. As used herein, the term “antioxidant” refers to asubstance which prevents or suppresses oxidation by terminating freeradical reactions, and may delay or prevent some types of cellulardamage. Antioxidants may be naturally occurring or synthetic. Naturallyoccurring antioxidants include those found in foods and botanicalmaterials. Non-limiting examples of antioxidants include certainbotanical materials, vitamins, polyphenols, and phenol derivatives.

Examples of botanical materials which are associated with antioxidantcharacteristics include without limitation acai berry, alfalfa,allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot,black pepper, blueberries, borage seed oil, bugleweed, cacao, calamusroot, catnip, catuaba, cayenne pepper, chaga mushroom, chervil,cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingkobiloba, Saint John's Wort, saw palmetto, green tea, black tea, blackcohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion,grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew,ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava,lavender, licorice, marjoram, milk thistle, mints (menthe), oolong tea,beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover,rooibos (red or green), rosehip, rosemary, sage, clary sage, savory,spearmint, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghumgrain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutukola, thyme, turmeric, Uva ursi, valerian, wild yam root, wintergreen,yacon root, yellow dock, yerba mate, yerba santa, Bacopa monniera,Withania somnifera, Lion's mane, and Silybum marianum. Such botanicalmaterials may be provided in fresh or dry form, essential oils, or maybe in the form of an extracts. The botanical materials (as well as theirextracts) often include compounds from various classes known to provideantioxidant effects, such as minerals, vitamins, isoflavones,phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles,lignans, flavonoids, polyphenols, and carotenoids. Examples of compoundsfound in botanical extracts or oils include ascorbic acid, peanutendocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein,co-enzyme Q, carnitine, quercetin, kaempferol, and the like. See, e.g.,Santhosh et al., Phytomedicine, 12(2005) 216-220, which is incorporatedherein by reference.

Non-limiting examples of other suitable antioxidants include citricacid, Vitamin E or a derivative thereof, a tocopherol, epicatechol,epigallocatechol, epigallocatechol gallate, erythorbic acid, sodiumerythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A orB, theaflavin digallate, phenolic acids, glycosides, quercitrin,isoquercitrin, hyperoside, polyphenols, catechols, resveratrols,oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene(BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.

When present, an antioxidant is typically at a concentration of fromabout 0.001% w/w to about 10% by weight, such as, e.g., from about0.001%, about 0.005%, about 0.01% w/w, about 0.05%, about 0.1%, or about0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,about 7%, about 8%, about 9%, or about 10%, based on the total weight ofthe composition.

Nicotine Component

In certain embodiments, the active ingredient comprises a nicotinecomponent. By “nicotine component” is meant any suitable form ofnicotine (e.g., free base or salt) for providing oral absorption of atleast a portion of the nicotine present. Typically, the nicotinecomponent is selected from the group consisting of nicotine free baseand a nicotine salt. In some embodiments, the nicotine component isnicotine in its free base form, which easily can be adsorbed in forexample, a microcrystalline cellulose material to form amicrocrystalline cellulose-nicotine carrier complex. See, for example,the discussion of nicotine in free base form in U.S. Pat. Pub. No.2004/0191322 to Hansson, which is incorporated herein by reference.

In some embodiments, at least a portion of the nicotine component can beemployed in the form of a salt. Salts of nicotine can be provided usingthe types of ingredients and techniques set forth in U.S. Pat. No.2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Additionally,salts of nicotine are available from sources such as Pfaltz and Bauer,Inc. and K & K Laboratories, Division of ICN Biochemicals, Inc.Typically, the nicotine component is selected from the group consistingof nicotine free base, a nicotine salt such as hydrochloride,dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, andnicotine zinc chloride.

In some embodiments, at least a portion of the nicotine can be in theform of a resin complex of nicotine, where nicotine is bound in anion-exchange resin, such as nicotine polacrilex, which is nicotine boundto, for example, a polymethacrylic acid, such as Amberlite IRP64,Purolite C115HMR, or Doshion P551. See, for example, U.S. Pat. No.3,901,248 to Lichtneckert et al., which is incorporated herein byreference. Another example is a nicotine-polyacrylic carbomer complex,such as with Carbopol 974P. In some embodiments, nicotine may be presentin the form of a nicotine polyacrylic complex.

Typically, the nicotine component (calculated as the free base) whenpresent, is in a concentration of at least about 0.001% by weight of thecomposition, such as in a range from about 0.001% to about 10%. In someembodiments, the nicotine component is present in a concentration fromabout 0.1% w/w to about 10% by weight, such as, e.g., from about 0.1%w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% byweight, calculated as the free base and based on the total weight of thecomposition. In some embodiments, the nicotine component is present in aconcentration from about 0.1% w/w to about 3% by weight, such as, e.g.,from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, fromabout 0.1% to about 1.5%, or from about 0.1% to about 1% by weight,calculated as the free base and based on the total weight of thecomposition.

In some embodiments, the products or compositions of the disclosure canbe characterized as free of any nicotine component (e.g., any embodimentas disclosed herein may be completely or substantially free of anynicotine component). By “substantially free” is meant that no nicotinehas been intentionally added, beyond trace amounts that may be naturallypresent in e.g., a botanical material. For example, certain embodimentscan be characterized as having less than 0.001% by weight of nicotine,or less than 0.0001%, or even 0% by weight of nicotine, calculated asthe free base.

In some embodiments, the active ingredient comprises a nicotinecomponent (e.g., any product or composition of the disclosure, inaddition to comprising any active ingredient or combination of activeingredients as disclosed herein, may further comprise a nicotinecomponent).

In one or more embodiments, an amount of a nicotine component that maybe present in the compositions and products can be at least partiallyrelated to the total moisture content of the compositions and products.Accordingly, it can be desirable for the nicotine component content andthe total moisture content to be within a desired ratio. For example, insome embodiments, a weight to weight ratio of total nicotine content tototal moisture content can be substantially low and thus may be in therange of about 0.01 to about 0.2, about 0.02 to about 0.1, or about 0.03to about 0.08.

In some embodiments, it can be desirable to provide compositions andproducts having a relatively high nicotine content. For example, in suchembodiments, the nicotine component may be present in an amount ofgreater than 2%, greater than 2.5%, greater than 3%, or greater than3.5% by weight based on the total weight of the composition or product.In another embodiment, the nicotine component may be present in anamount of about 2% to about 10%, about 3% to about 10%, or about 4% toabout 8% by weight based on the total weight of the oral composition.Where nicotine is present in a relatively high content, it can likewisebe desirable for the total moisture content of the compositions andproducts to be relatively high. For example, a suitable total moisturecontent may be greater than 20%, greater than 25%, greater than 30%, orgreater than 35% by weight based on the total weight of the compositionor product. Further, the total moisture content may be in the range ofabout 20% to about 60%, about 25% to about 55%, about 30% to about 50%,or about 20% to about 45% by weight based on the total weight of thecomposition or product. In addition to the foregoing, it may bedesirable in some embodiments for the present compositions and productsto be substantially or completely free of any tobacco material. This maybe particularly the case in compositions having a relatively highnicotine content and/or high water content; however, the express absenceof any tobacco may be applied to other embodiments of the presentdisclosure. As further described herein, it can be desirable in someembodiments for the compositions or products to exhibit a defined pH,which may be achieved through the use of suitable buffers or overallcombination of materials in light of their natural acidity level (highor low). In some embodiments, such as where a high nicotine, highmoisture content product is desired, it may be useful to control theoverall composition (include the addition or exclusion of any buffers)to provide a pH that is greater than 7, greater than 7.5, greater than8, or greater than 8.5. In particular, pH for such compositions may bein the range of about 7.5 to about 11, 7.5 to about 10, or about 8 toabout 9.5. In certain embodiments, it thus may be useful to providecompositions or products having a relatively high nicotine content, arelatively high water content, expressly exclude tobacco, and optionallyhave a pH within the above-noted ranges.

In some embodiments, it can be useful to provide compositions andproducts having a relatively low nicotine content. For example, in suchembodiments, the nicotine component may be present in an amount of lessthan 1%, less than 0.8%, less than 0.7%, or less than 0.5% by weightbased on the total weight of the composition or product. In anotherembodiment, the nicotine component may be present in an amount of about0.01% to about 0.9%, about 0.05% to about 0.8%, about 0.1% to about0.7%, or about 0.2% to about 0.5% by weight based on the total weight ofthe composition or product. Where nicotine is present in a relativelylow content, it can be desirable for the total moisture content of thecompositions and products to be within a defined range. For example, asuitable total moisture content may be in the range of about 10% toabout 40%, about 15% to about 30%, or about 20% to about 30% by weightbased on the total weight of the composition or product.

Cannabinoids

In some embodiments, the active ingredient comprises one or morecannabinoids. As used herein, the term “cannabinoid” refers to a classof diverse chemical compounds that acts on cannabinoid receptors, alsoknown as the endocannabinoid system, in cells that alterneurotransmitter release in the brain. Ligands for these receptorproteins include the endocannabinoids produced naturally in the body byanimals; phytocannabinoids, found in cannabis; and syntheticcannabinoids, manufactured artificially. Cannabinoids found in cannabisinclude, without limitation: cannabigerol (CBG), cannabichromene (CBC),cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN),cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV),tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin(CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propylvariant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA),and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, thecannabinoid is selected from tetrahydrocannabinol (THC), the primarypsychoactive compound in cannabis, and cannabidiol (CBD) another majorconstituent of the plant, but which is devoid of psychoactivity. All ofthe above compounds can be used in the form of an isolate from plantmaterial or synthetically derived.

Alternatively, the active ingredient can be a cannabimimetic, which is aclass of compounds derived from plants other than cannabis that havebiological effects on the endocannabinoid system similar tocannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin(also classified as terpenes), cyanidin, curcumin (tumeric), catechin,quercetin, salvinorin A, N-acylethanolamines, and N-alkylamide lipids.

When present, a cannabinoid (e.g., CBD) or cannabimimetic is typicallyin a concentration of at least about 0.1% by weight of the composition,such as in a range from about 0.1% to about 30%, such as, e.g., fromabout 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 15%, about 20%, or about 30% by weight, based on the total weightof the composition.

Terpenes

Active ingredients suitable for use in the present disclosure can alsobe classified as terpenes, many of which are associated with biologicaleffects, such as calming effects. Terpenes are understood to have thegeneral formula of (C₅H₈)_(n) and include monoterpenes, sesquiterpenes,and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic instructure. Some terpenes provide an entourage effect when used incombination with cannabinoids or cannabimimetics. Examples includebeta-caryophyllene, linalool, limonene, beta-citronellol, linalylacetate, pinene (alpha or beta), geraniol, carvone, eucalyptol,menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, andgermacrene, which may be used singly or in combination.

Pharmaceutical Ingredients

In some embodiments, the active ingredient comprises an activepharmaceutical ingredient (API). The API can be any known agent adaptedfor therapeutic, prophylactic, or diagnostic use. These can include, forexample, synthetic organic compounds, proteins and peptides,polysaccharides and other sugars, lipids, phospholipids, inorganiccompounds (e.g., magnesium, selenium, zinc, nitrate), neurotransmittersor precursors thereof (e.g., serotonin, 5-hydroxytryptophan, oxitriptan,acetylcholine, dopamine, melatonin), and nucleic acid sequences, havingtherapeutic, prophylactic, or diagnostic activity. Non-limiting examplesof APIs include analgesics and antipyretics (e.g., acetylsalicylic acid,acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine,myoinositol, docosahexaenoic acid (DHA, Omega-3), arachidonic acid (AA,Omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-methylbutyrate(HMB), citicoline (cytidine-5′-diphosphate-choline), and cotinine. Insome embodiments, the active ingredient comprises citicoline. In someembodiments, the active ingredient is a combination of citicoline,caffeine, theanine, and ginseng. In some embodiments, the activeingredient comprises sunflower lecithin. In some embodiments, the activeingredient is a combination of sunflower lecithin, caffeine, theanine,and ginseng.

The amount of API may vary. For example, when present, an API istypically at a concentration of from about 0.001% w/w to about 10% byweight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1%, to about 2%,about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, orabout 10% by weight, based on the total weight of the composition.

In some embodiments, the composition is substantially free of any API.By “substantially free of any API” means that the composition does notcontain, and specifically excludes, the presence of any API as definedherein, such as any Food and Drug Administration (FDA) approvedtherapeutic agent intended to treat any medical condition.

Flavoring Agents

In some embodiments, a releasable material may be one or more flavoringagent. As used herein, a “flavoring agent” or “flavorant” is anyflavorful or aromatic substance capable of altering the sensorycharacteristics associated with the oral product. Examples of sensorycharacteristics that can be modified by the flavoring agent includetaste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma.Flavoring agents may be natural or synthetic, and the character of theflavors imparted thereby may be described, without limitation, as fresh,sweet, herbal, confectionary, floral, fruity, or spicy. In someembodiments, the releasable material may include a single flavoringagent or a plurality of flavoring agents. If desired, one or moreflavoring agents may be retained on a portion of a carrier or filler,and one or more flavoring agents may be otherwise retained in thecompositions and/or products, such as being bound to a further carrieror filler.

Non-limiting examples of flavoring agents that may be used as areleasable material herein and/or be otherwise included within thepresent compositions and/or products can include vanilla, coffee,chocolate/cocoa, cream, mint, spearmint, menthol, peppermint,wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove,cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice,lemon, orange, apple, peach, lime, cherry, strawberry, trigeminalsensates, terpenes, and any combinations thereof. See also, Leffingwellet al., Tobacco Flavoring for Smoking Products, R. J. Reynolds TobaccoCompany (1972), which is incorporated herein by reference. Flavoringagents may comprise components such as terpenes, terpenoids, aldehydes,ketones, esters, and the like. In some embodiments, the flavoring agentis a trigeminal sensate. As used herein, “trigeminal sensate” refers toa flavoring agent which has an effect on the trigeminal nerve, producingsensations including heating, cooling, tingling, and the like.Non-limiting examples of trigeminal sensate flavoring agents includecapsaicin, citric acid, menthol, Sichuan buttons, erythritol, andcubebol. Flavorings also may include components that are consideredmoistening, cooling or smoothening agents, such as eucalyptus. Theseflavors may be provided neat (i.e., alone) or in a composite, and may beemployed as concentrates or flavor packages (e.g., spearmint andmenthol, orange and cinnamon; lime, pineapple, and the like).Representative types of components also are set forth in U.S. Pat. No.5,387,416 to White et al.; U.S. Pat. App. Pub. No. 2005/0244521 toStrickland et al.; and PCT Application Pub. No. WO 05/041699 to Quinteret al., each of which is incorporated herein by reference. In someinstances, the flavoring agent may be provided in a spray-dried form ora liquid form.

The flavoring agent generally comprises at least one volatile flavorcomponent. As used herein, “volatile” refers to a chemical substancethat forms a vapor readily at ambient temperatures (i.e., a chemicalsubstance that has a high vapor pressure at a given temperature relativeto a nonvolatile substance). Typically, a volatile flavor component hasa molecular weight below about 400 Da, and often include at least onecarbon-carbon double bond, carbon-oxygen double bond, or both. In oneembodiment, the at least one volatile flavor component comprises one ormore alcohols, aldehydes, aromatic hydrocarbons, ketones, esters,terpenes, terpenoids, or a combination thereof. Non-limiting examples ofaldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal,furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, andcitronellal. Non-limiting examples of ketones include1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one.Non-limiting examples of esters include allyl hexanoate, ethylheptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate.Non-limiting examples of terpenes include sabinene, limonene,gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol,nerol, citronellol, linalool, and eucalyptol. In one embodiment, the atleast one volatile flavor component comprises one or more of ethylvanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene,beta-farnesene, or citral. In one embodiment, the at least one volatileflavor component comprises ethyl vanillin.

The amount of flavoring agent utilized in the mixture can vary, but istypically up to about 10 weight percent, and certain embodiments arecharacterized by a flavoring agent content of at least about 0.1 weightpercent, such as about 0.5 to about 10 weight percent, about 1 to about6 weight percent, or about 2 to about 5 weight percent, based on thetotal weight of the mixture.

Tobacco Material

In some embodiments, the present compositions and/or products mayinclude a tobacco material. The tobacco material can vary in species,type, and form. Generally, the tobacco material is obtained from for aharvested plant of the Nicotiana species. Example Nicotiana speciesinclude N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N.forgetiana, N. glauca, N. glutinosa, N. gossei, N. kawakamii, N.knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N.tomentosa, N. tomentosiformis, N. undulata, N. x sanderae, N. africana,N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N.longiflora, N. maritina, N. megalosiphon, N. occidentalis, N.paniculata, N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans,N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N.wigandioides, N. acaulis, N. acuminata, N. attenuata, N. benthamiana, N.cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. fragrans, N.goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N.occidentalis subsp. Hersperis, N. pauciflora, N. petunioides, N.quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N.spegazzinii. Various representative other types of plants from theNicotiana species are set forth in Goodspeed, The Genus Nicotiana,(Chonica Botanica) (1954); U.S. Pat. No. 4,660,577 to Sensabaugh, Jr. etal.; U.S. Pat. No. 5,387,416 to White et al., U.S. Pat. No. 7,025,066 toLawson et al.; U.S. Pat. No. 7,798,153 to Lawrence, Jr. and U.S. Pat.No. 8,186,360 to Marshall et al.; each of which is incorporated hereinby reference. Descriptions of various types of tobaccos, growingpractices and harvesting practices are set forth in Tobacco Production,Chemistry and Technology, Davis et al. (Eds.) (1999), which isincorporated herein by reference.

Nicotiana species from which suitable tobacco materials can be obtainedcan be derived using genetic-modification or crossbreeding techniques(e.g., tobacco plants can be genetically engineered or crossbred toincrease or decrease production of components, characteristics orattributes). See, for example, the types of genetic modifications ofplants set forth in U.S. Pat. No. 5,539,093 to Fitzmaurice et al.; U.S.Pat. No. 5,668,295 to Wahab et al.; U.S. Pat. No. 5,705,624 toFitzmaurice et al.; U.S. Pat. No. 5,844,119 to Weigl; U.S. Pat. No.6,730,832 to Dominguez et al.; U.S. Pat. No. 7,173,170 to Liu et al.;U.S. Pat. No. 7,208,659 to Colliver et al. and U.S. Pat. No. 7,230,160to Benning et al.; U.S. patent appl. Pub. No. 2006/0236434 to Conklinget al.; and PCT WO2008/103935 to Nielsen et al. See, also, the types oftobaccos that are set forth in U.S. Pat. No. 4,660,577 to Sensabaugh,Jr. et al.; U.S. Pat. No. 5,387,416 to White et al.; and U.S. Pat. No.6,730,832 to Dominguez et al., each of which is incorporated herein byreference.

The Nicotiana species can, in some embodiments, be selected for thecontent of various compounds that are present therein. For example,plants can be selected on the basis that those plants produce relativelyhigh quantities of one or more of the compounds desired to be isolatedtherefrom. In certain embodiments, plants of the Nicotiana species(e.g., Galpao commun tobacco) are specifically grown for their abundanceof leaf surface compounds. Tobacco plants can be grown in greenhouses,growth chambers, or outdoors in fields, or grown hydroponically.

Various parts or portions of the plant of the Nicotiana species can beincluded within a mixture as disclosed herein. For example, virtuallyall of the plant (e.g., the whole plant) can be harvested, and employedas such. Alternatively, various parts or pieces of the plant can beharvested or separated for further use after harvest. For example, theflower, leaves, stem, stalk, roots, seeds, and various combinationsthereof, can be isolated for further use or treatment. In someembodiments, the tobacco material comprises tobacco leaf (lamina). Themixture disclosed herein can include processed tobacco parts or pieces,cured and aged tobacco in essentially natural lamina and/or stem form, atobacco extract, extracted tobacco pulp (e.g., using water as asolvent), or a mixture of the foregoing (e.g., a mixture that combinesextracted tobacco pulp with granulated cured and aged natural tobaccolamina).

In certain embodiments, the tobacco material comprises solid tobaccomaterial selected from the group consisting of lamina and stems. Thetobacco that is used for the mixture most preferably includes tobaccolamina, or a tobacco lamina and stem mixture (of which at least aportion is smoke-treated). Portions of the tobaccos within the mixturemay have processed forms, such as processed tobacco stems (e.g.,cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), orvolume expanded tobacco (e.g., puffed tobacco, such as dry ice expandedtobacco (DIET)). See, for example, the tobacco expansion processes setforth in U.S. Pat. No. 4,340,073 to de la Burde et al.; U.S. Pat. No.5,259,403 to Guy et al.; and U.S. Pat. No. 5,908,032 to Poindexter, etal.; and U.S. Pat. No. 7,556,047 to Poindexter, et al., all of which areincorporated by reference. In addition, the d mixture optionally mayincorporate tobacco that has been fermented. See, also, the types oftobacco processing techniques set forth in PCT WO2005/063060 to Atchleyet al., which is incorporated herein by reference.

The tobacco material is typically used in a form that can be describedas particulate (i.e., shredded, ground, granulated, or powder form). Themanner by which the tobacco material is provided in a finely divided orpowder type of form may vary. Preferably, plant parts or pieces arecomminuted, ground or pulverized into a particulate form using equipmentand techniques for grinding, milling, or the like. Most preferably, theplant material is relatively dry in form during grinding or milling,using equipment such as hammer mills, cutter heads, air control mills,or the like. For example, tobacco parts or pieces may be ground ormilled when the moisture content thereof is less than about 15 weightpercent or less than about 5 weight percent. Most preferably, thetobacco material is employed in the form of parts or pieces that have anaverage particle size between 1.4 millimeters and 250 microns. In someinstances, the tobacco particles may be sized to pass through a screenmesh to obtain the particle size range required. If desired, airclassification equipment may be used to ensure that small sized tobaccoparticles of the desired sizes, or range of sizes, may be collected. Ifdesired, differently sized pieces of granulated tobacco may be mixedtogether.

The manner by which the tobacco is provided in a finely divided orpowder type of form may vary. Preferably, tobacco parts or pieces arecomminuted, ground or pulverized into a powder type of form usingequipment and techniques for grinding, milling, or the like. Mostpreferably, the tobacco is relatively dry in form during grinding ormilling, using equipment such as hammer mills, cutter heads, air controlmills, or the like. For example, tobacco parts or pieces may be groundor milled when the moisture content thereof is less than about 15 weightpercent to less than about 5 weight percent. For example, the tobaccoplant or portion thereof can be separated into individual parts orpieces (e.g., the leaves can be removed from the stems, and/or the stemsand leaves can be removed from the stalk). The harvested plant orindividual parts or pieces can be further subdivided into parts orpieces (e.g., the leaves can be shredded, cut, comminuted, pulverized,milled or ground into pieces or parts that can be characterized asfiller-type pieces, granules, particulates or fine powders). The plant,or parts thereof, can be subjected to external forces or pressure (e.g.,by being pressed or subjected to roll treatment). When carrying out suchprocessing conditions, the plant or portion thereof can have a moisturecontent that approximates its natural moisture content (e.g., itsmoisture content immediately upon harvest), a moisture content achievedby adding moisture to the plant or portion thereof, or a moisturecontent that results from the drying of the plant or portion thereof.For example, powdered, pulverized, ground or milled pieces of plants orportions thereof can have moisture contents of less than about 25 weightpercent, often less than about 20 weight percent, and frequently lessthan about 15 weight percent.

For the preparation of oral products, it is typical for a harvestedplant of the Nicotiana species to be subjected to a curing process. Thetobacco materials incorporated within the mixture for inclusion withinproducts as disclosed herein are those that have been appropriatelycured and/or aged. Descriptions of various types of curing processes forvarious types of tobaccos are set forth in Tobacco Production, Chemistryand Technology, Davis et al. (Eds.) (1999). Examples of techniques andconditions for curing flue-cured tobacco are set forth in Nestor et al.,Beitrage Tabakforsch. Int., 20, 467-475 (2003) and U.S. Pat. No.6,895,974 to Peele, which are incorporated herein by reference.Representative techniques and conditions for air curing tobacco are setforth in U.S. Pat. No. 7,650,892 to Groves et al.; Roton et al.,Beitrage Tabakforsch. Int., 21, 305-320 (2005) and Staaf et al.,Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are incorporatedherein by reference. Certain types of tobaccos can be subjected toalternative types of curing processes, such as fire curing or suncuring.

In certain embodiments, tobacco materials that can be employed includeflue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., IndianKurnool and Oriental tobaccos, including Katerini, Prelip, Komotini,Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured(e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobaccos), light aircured (e.g., North Wisconsin and Galpao tobaccos), Indian air cured, RedRussian and Rustica tobaccos, as well as various other rare or specialtytobaccos and various blends of any of the foregoing tobaccos.

The tobacco material may also have a so-called “blended” form. Forexample, the tobacco material may include a mixture of parts or piecesof flue-cured, burley (e.g., Malawi burley tobacco) and Orientaltobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina,or a mixture of tobacco lamina and tobacco stem). For example, arepresentative blend may incorporate about 30 to about 70 parts burleytobacco (e.g., lamina, or lamina and stem), and about 30 to about 70parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on adry weight basis. Other example tobacco blends incorporate about 75parts flue-cured tobacco, about 15 parts burley tobacco, and about 10parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 25parts burley tobacco, and about 10 parts Oriental tobacco; or about 65parts flue-cured tobacco, about 10 parts burley tobacco, and about 25parts Oriental tobacco; on a dry weight basis. Other example tobaccoblends incorporate about 20 to about 30 parts Oriental tobacco and about70 to about 80 parts flue-cured tobacco on a dry weight basis.

Tobacco materials used in the present disclosure can be subjected to,for example, fermentation, bleaching, and the like. If desired, thetobacco materials can be, for example, irradiated, pasteurized, orotherwise subjected to controlled heat treatment. Such treatmentprocesses are detailed, for example, in U.S. Pat. No. 8,061,362 to Muaet al., which is incorporated herein by reference. In certainembodiments, tobacco materials can be treated with water and an additivecapable of inhibiting reaction of asparagine to form acrylamide uponheating of the tobacco material (e.g., an additive selected from thegroup consisting of lysine, glycine, histidine, alanine, methionine,cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine,arginine, compositions incorporating di- and trivalent cations,asparaginase, certain non-reducing saccharides, certain reducing agents,phenolic compounds, certain compounds having at least one free thiolgroup or functionality, oxidizing agents, oxidation catalysts, naturalplant extracts (e.g., rosemary extract), and combinations thereof. See,for example, the types of treatment processes described in U.S. Pat.Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., which are allincorporated herein by reference. In certain embodiments, this type oftreatment is useful where the original tobacco material is subjected toheat in the processes previously described.

In some embodiments, the type of tobacco material is selected such thatit is initially visually lighter in color than other tobacco materialsto some degree (e.g., whitened or bleached). Tobacco pulp can bewhitened in certain embodiments according to any means known in the art.For example, bleached tobacco material produced by various whiteningmethods using various bleaching or oxidizing agents and oxidationcatalysts can be used. Example oxidizing agents include peroxides (e.g.,hydrogen peroxide), chlorite salts, chlorate salts, perchlorate salts,hypochlorite salts, ozone, ammonia, potassium permanganate, andcombinations thereof. Example oxidation catalysts are titanium dioxide,manganese dioxide, and combinations thereof. Processes for treatingtobacco with bleaching agents are discussed, for example, in U.S. patentNos. 787,611 to Daniels, Jr.; 1,086,306 to Oelenheinz; U.S. Pat. No.1,437,095 to Delling; U.S. Pat. No. 1,757,477 to Rosenhoch; U.S. Pat.No. 2,122,421 to Hawkinson; U.S. Pat. No. 2,148,147 to Baier; U.S. Pat.No. 2,170,107 to Baier; U.S. Pat. No. 2,274,649 to Baier; U.S. Pat. No.2,770,239 to Prats et al.; U.S. Pat. No. 3,612,065 to Rosen; U.S. Pat.No. 3,851,653 to Rosen; U.S. Pat. No. 3,889,689 to Rosen; U.S. Pat. No.3,943,940 to Minami; U.S. Pat. No. 3,943,945 to Rosen; U.S. Pat. No.4,143,666 to Rainer; U.S. Pat. No. 4,194,514 to Campbell; U.S. Pat. Nos.4,366,823, 4,366,824, and 4,388,933 to Rainer et al.; U.S. Pat. No.4,641,667 to Schmekel et al.; U.S. Pat. No. 5,713,376 to Berger; U.S.Pat. No. 9,339,058 to Byrd Jr. et al.; U.S. Pat. No. 9,420,825 to Beesonet al.; and U.S. Pat. No. 9,950,858 to Byrd Jr. et al.; as well as inU.S. pat. app. Pub. Nos. 2012/0067361 to Bjorkholm et al.; 2016/0073686to Crooks; 2017/0020183 to Bjorkholm; and 2017/0112183 to Bjorkholm, andin PCT Publ. application. Nos. WO1996/031255 to Giolvas andWO2018/083114 to Bjorkholm, all of which are incorporated herein byreference.

In some embodiments, the whitened tobacco material can have an ISObrightness of at least about 50%, at least about 60%, at least about65%, at least about 70%, at least about 75%, or at least about 80%. Insome embodiments, the whitened tobacco material can have an ISObrightness in the range of about 50% to about 90%, about 55% to about75%, or about 60% to about 70%. ISO brightness can be measured accordingto ISO 3688:1999 or ISO 2470-1:2016.

In some embodiments, the whitened tobacco material can be characterizedas lightened in color (e.g., “whitened”) in comparison to an untreatedtobacco material. White colors are often defined with reference to theInternational Commission on Illumination's (CIE's) chromaticity diagram.The whitened tobacco material can, in certain embodiments, becharacterized as closer on the chromaticity diagram to pure white thanan untreated tobacco material.

In various embodiments, the tobacco material can be treated to extract asoluble component of the tobacco material therefrom. “Tobacco extract”as used herein refers to the isolated components of a tobacco materialthat are extracted from solid tobacco pulp by a solvent that is broughtinto contact with the tobacco material in an extraction process. Variousextraction techniques of tobacco materials can be used to provide atobacco extract and tobacco solid material. See, for example, theextraction processes described in U.S. Pat. Appl. Pub. No. 2011/0247640to Beeson et al., which is incorporated herein by reference. Otherexample techniques for extracting components of tobacco are described inU.S. Pat. No. 4,144,895 to Fiore; U.S. Pat. No. 4,150,677 to Osborne,Jr. et al.; 4,267,847 to Reid; U.S. Pat. No. 4,289,147 to Wildman etal.; U.S. Pat. No. 4,351,346 to Brummer et al.; U.S. Pat. No. 4,359,059to Brummer et al.; U.S. Pat. No. 4,506,682 to Muller; U.S. Pat. No.4,589,428 to Keritsis; U.S. Pat. No. 4,605,016 to Soga et al.; U.S. Pat.No. 4,716,911 to Poulose et al.; U.S. Pat. No. 4,727,889 to Niven, Jr.et al.; U.S. Pat. No. 4,887,618 to Bernasek et al.; U.S. Pat. No.4,941,484 to Clapp et al.; U.S. Pat. No. 4,967,771 to Fagg et al.; U.S.Pat. No. 4,986,286 to Roberts et al.; U.S. Pat. No. 5,005,593 to Fagg etal.; U.S. Pat. No. 5,018,540 to Grubbs et al.; U.S. Pat. No. 5,060,669to White et al.; U.S. Pat. No. 5,065,775 to Fagg; U.S. Pat. No.5,074,319 to White et al.; U.S. Pat. No. 5,099,862 to White et al.; U.S.Pat. No. 5,121,757 to White et al.; U.S. Pat. No. 5,131,414 to Fagg;U.S. Pat. No. 5,131,415 to Munoz et al.; U.S. Pat. No. 5,148,819 toFagg; U.S. Pat. No. 5,197,494 to Kramer; U.S. Pat. No. 5,230,354 toSmith et al.; U.S. Pat. No. 5,234,008 to Fagg; U.S. Pat. No. 5,243,999to Smith; U.S. Pat. No. 5,301,694 to Raymond et al.; U.S. Pat. No.5,318,050 to Gonzalez-Parra et al.; U.S. Pat. No. 5,343,879 to Teague;U.S. Pat. No. 5,360,022 to Newton; U.S. Pat. No. 5,435,325 to Clapp etal.; U.S. Pat. No. 5,445,169 to Brinkley et al.; U.S. Pat. No. 6,131,584to Lauterbach; U.S. Pat. No. 6,298,859 to Kierulff et al.; U.S. Pat. No.6,772,767 to Mua et al.; and U.S. Pat. No. 7,337,782 to Thompson, all ofwhich are incorporated by reference herein.

Typical inclusion ranges for tobacco materials can vary depending on thenature and type of the tobacco material, and the intended effect on thefinal mixture, with an example range of up to about 30% by weight (or upto about 20% by weight or up to about 10% by weight or up to about 5% byweight), based on total weight of the mixture (e.g., about 0.1 to about15% by weight). In some embodiments, the products of the disclosure canbe characterized as completely free or substantially free of tobaccomaterial (other than purified nicotine as an active ingredient). Forexample, certain embodiments can be characterized as having less than 1%by weight, or less than 0.5% by weight, or less than 0.1% by weight oftobacco material, or 0% by weight of tobacco material. In someembodiments, a composition or product according to the presentdisclosure may comprise no more than about 10% by weight of a tobaccomaterial, excluding any nicotine component present, based on the totalweight of the mixture.

Further Additives

In some embodiments, one or more further additives can be included inthe disclosed compositions and/or products. For example, thecompositions can be processed, blended, formulated, combined and/ormixed with other materials or ingredients. The additives can beartificial, or can be obtained or derived from herbal or biologicalsources. Specific types of further additives that may be included arefurther described below.

In some embodiments, the compositions and products may include a contentof water. The water content (or total moisture content) of thecomposition within the product, prior to use by a consumer of theproduct, may vary according to the desired properties. Typically, thecomposition, as present within the product prior to insertion into themouth of the user, can comprise less than 60%, less than 50%, less than40%, less than 30%, less than 20%, less than 10%, or less than 5% byweight of water. For example, total water content in the compositionand/or product may be in the range of about 0.1% to about 60%, about 1%to about 50%, about 1.5% to about 40%, or about 2% to about 25% byweight of water. In some embodiments, the compositions and products mayinclude at least 1%, at least 2%, at least 5%, at least 10%, or at least20% by weight water. As already described above, the water content insome embodiments, may be at least partially related to the content ofother components of the composition, such as a nicotine content or acontent of another active agent. Likewise, water content (or totalmoisture content) may vary in relation to the use of a binder component,as otherwise described below. For example, water content or totalmoisture content may be in the range of about 10% to about 40%, about15% to about 35%, or about 15% to about 30% by weight based on the totalweight of the composition or product.

In some embodiments, the compositions and products may include a contentof one or more organic acids. As used herein, the term “organic acid”refers to an organic (i.e., carbon-based) compound that is characterizedby acidic properties. Typically, organic acids are relatively weak acids(i.e., they do not dissociate completely in the presence of water), suchas carboxylic acids (—CO₂H) or sulfonic acids (—SO₂OH). As used herein,reference to organic acid means an organic acid that is intentionallyadded. In this regard, an organic acid may be intentionally added as aspecific ingredient as opposed to merely being inherently present as acomponent of another ingredient (e.g., the small amount of organic acidwhich may inherently be present in an ingredient such as a tobaccomaterial). In some embodiments, the one or more organic acids are addedneat (i.e., in their free acid, native solid or liquid form) or as asolution in, e.g., water. In some embodiments, the one or more organicacids are added in the form of a salt, as described herein below.

In some embodiments, the organic acid is an alkyl carboxylic acid.Non-limiting examples of alkyl carboxylic acids include formic acid,acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoicacid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid,linoleic acid, linolenic acid, and the like. In some embodiments, theorganic acid is an alkyl sulfonic acid. Non-limiting examples of alkylsulfonic acids include propanesulfonic acid and octanesulfonic acid. Insome embodiments, the alkyl carboxylic or sulfonic acid is substitutedwith one or more hydroxyl groups. Non-limiting examples include glycolicacid, 4-hydroxybutyric acid, and lactic acid. In some embodiments, anorganic acid may include more than one carboxylic acid group or morethan one sulfonic acid group (e.g., two, three, or more carboxylic acidgroups). Non-limiting examples include oxalic acid, fumaric acid, maleicacid, and glutaric acid. In organic acids containing multiple carboxylicacids (e.g., from two to four carboxylic acid groups), one or more ofthe carboxylic acid groups may be esterified. Non-limiting examplesinclude succinic acid monoethyl ester, monomethyl fumarate, monomethylor dimethyl citrate, and the like.

In some embodiments, the organic acid may include more than onecarboxylic acid group and one or more hydroxyl groups. Non-limitingexamples of such acids include tartaric acid, citric acid, and the like.In some embodiments, the organic acid is an aryl carboxylic acid or anaryl sulfonic acid. Non-limiting examples of aryl carboxylic andsulfonic acids include benzoic acid, toluic acids, salicylic acid,benzenesulfonic acid, and p-toluenesulfonic acid. In some embodiments,the organic acid is citric acid, malic acid, tartaric acid, octanoicacid, benzoic acid, a toluic acid, salicylic acid, or a combinationthereof. In some embodiments, the organic acid is benzoic acid. In someembodiments, the organic acid is citric acid. In alternativeembodiments, a portion, or even all, of the organic acid may be added inthe form of a salt with an alkaline component, which may include, but isnot limited to, nicotine. Non-limiting examples of suitable salts, e.g.,for nicotine, include formate, acetate, propionate, isobutyrate,butyrate, alpha-methylbutyrate, isovalerate, beta-methylvalerate,caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate,oxalate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate,fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate,succinate, pyruvate, and the like.

The amount of organic acid present in the compositions may vary.Generally, the compositions can comprise from 0 to about 10% by weightof organic acid, present as one or more organic acids, based on thetotal weight of the mixture.

In some embodiments, the compositions may further comprise a salt (e.g.,alkali metal salts), typically employed in an amount sufficient toprovide desired sensory attributes to the compositions and products.Non-limiting examples of suitable salts include sodium chloride,potassium chloride, ammonium chloride, flour salt, and the like. Whenpresent, a representative amount of salt is about 0.5 percent by weightor more, about 1.0 percent by weight or more, or at about 1.5 percent byweight or more, but will typically make up about 10 percent or less ofthe total weight of the composition or product, or about 7.5 percent orless or about 5 percent or less (e.g., about 0.5 to about 5 percent byweight).

The compositions and products also may include one or more sweeteners.The sweeteners can be any sweetener or combination of sweeteners, innatural or artificial form, or as a combination of natural andartificial sweeteners. Examples of natural sweeteners include fructose,sucrose, glucose, maltose, mannose, galactose, lactose, isomaltulose,stevia, honey, and the like. Examples of artificial sweeteners includesucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame andthe like. In some embodiments, the sweetener comprises one or more sugaralcohols. Sugar alcohols are polyols derived from monosaccharides ordisaccharides that have a partially or fully hydrogenated form. Sugaralcohols have, for example, about 4 to about 20 carbon atoms and includeerythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol,mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,hydrogenated starch hydrolysates). When present, a representative amountof sweetener may make up from about 0.1 to about 20 percent or more ofthe of the composition by weight, for example, from about 0.1 to about1%, from about 1 to about 5%, from about 5 to about 10%, or from about10 to about 20% of the composition or product on a weight basis, basedon the total weight of the composition or product.

In some embodiments, the compositions and products may include one ormore binding agents. A binder (or combination of binders) may beemployed in certain embodiments, in amounts sufficient to provide thedesired physical attributes and physical integrity to the composition,and binders also often function as thickening or gelling agents. Typicalbinders can be organic or inorganic, or a combination thereof.Representative binders include povidone, sodium alginate, starch-basedbinders, pectin, carrageenan, pullulan, zein, and the like, andcombinations thereof. In some embodiments, the binder comprises pectinor carrageenan or combinations thereof.

The amount of binder utilized can vary, but is typically up to about 30weight percent, and certain embodiments are characterized by a bindercontent of at least about 0.1% by weight, such as about 1 to about 30%by weight, or about 5 to about 10% by weight, based on the total weightof the composition or product. As described above, one or more bindersmay be particularly useful in composition having a relatively moderateamount of moisture, such as in the range of about 15% to about 30% byweight water based on the total weight of the composition or product.Such compositions may be particularly suited for use with certain activeagents that have improved stability and/or improved release whencontained within a product having an overall moderate moisture content.

In certain embodiments, the binder includes a gum, for example, anatural gum. As used herein, a natural gum refers to polysaccharidematerials of natural origin that have binding properties, and which arealso useful as a thickening or gelling agents. Representative naturalgums derived from plants, which are typically water soluble to somedegree, include xanthan gum, guar gum, gum arabic, ghatti gum, gumtragacanth, karaya gum, locust bean gum, gellan gum, and combinationsthereof. When present, natural gum binder materials are typicallypresent in an amount of up to about 5% by weight, for example, fromabout 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about0.7, about 0.8, about 0.9, or about 1%, to about 2, about 3, about 4, orabout 5% by weight, based on the total weight of the composition orproduct.

In certain embodiments, one or more humectants may be employed in thecompositions. Examples of humectants include, but are not limited to,glycerin, propylene glycol, and the like. Where included, the humectantis typically provided in an amount sufficient to provide desiredmoisture attributes to the compositions. Further, in some instances, thehumectant may impart desirable flow characteristics to the compositionfor depositing in a mold. When present, a humectant will typically makeup about 5% or less of the weight of the composition or product (e.g.,from about 0.5 to about 5% by weight). When present, a representativeamount of humectant is about 0.1% to about 1% by weight, or about 1% toabout 5% by weight, based on the total weight of the composition orproduct.

In certain embodiments, the compositions of the present disclosure cancomprise pH adjusters or buffering agents. Examples of pH adjusters andbuffering agents that can be used include, but are not limited to, metalhydroxides (e.g., alkali metal hydroxides such as sodium hydroxide andpotassium hydroxide), and other alkali metal buffers such as metalcarbonates (e.g., potassium carbonate or sodium carbonate), or metalbicarbonates such as sodium bicarbonate, and the like. Where present,the buffering agent is typically present in an amount less than about 5percent based on the weight of the compositions or products, forexample, from about 0.5% to about 5%, such as, e.g., from about 0.75% toabout 4%, from about 0.75% to about 3%, or from about 1% to about 2% byweight, based on the total weight of the compositions or products.Non-limiting examples of suitable buffers include alkali metalsacetates, glycinates, phosphates, glycerophosphates, citrates,carbonates, hydrogen carbonates, borates, or mixtures thereof. As notedabove, it may be desirable in certain embodiments to provide a pH withina defined range, and the foregoing materials can be suitable for use inproviding compositions and products having the desired pH range.

In some embodiments, the compositions and products may include one ormore colorants. A colorant may be employed in amounts sufficient toprovide the desired physical attributes to the composition or product.Examples of colorants include various dyes and pigments, such as caramelcoloring and titanium dioxide. The amount of colorant utilized in thecompositions or products can vary, but when present is typically up toabout 3 weight percent, such as from about 0.1%, about 0.5%, or about1%, to about 3% by weight, based on the total weight of the compositionor product.

Examples of even further types of additives that may be used in thepresent compositions and products include thickening or gelling agents(e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil,eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate andthe like), disintegration aids, zinc or magnesium salts selected to berelatively water-soluble for compositions with greater water solubility(e.g., magnesium or zinc gluconate) or selected to be relativelywater-insoluble for compositions with reduced water solubility (e.g.,magnesium or zinc oxide), or combinations thereof. See, for example,those representative components, combination of components, relativeamounts of those components, and manners and methods for employing thosecomponents, set forth in U.S. Pat. No. 9,237,769 to Mua et al., U.S.Pat. No. 7,861,728 to Holton, Jr. et al., U.S. Pat. App. Pub. No.2010/0291245 to Gao et al., and U.S. Pat. App. Pub. No. 2007/0062549 toHolton, Jr. et al., each of which is incorporated herein by reference.Typical inclusion ranges for such additional additives can varydepending on the nature and function of the additive and the intendedeffect on the final mixture, with an example range of up to about 10% byweight, based on total weight of the mixture (e.g., about 0.1 to about5% by weight).

In one or more embodiments, the present compositions and products mayinclude one or more complexing agents, such as a cyclodextrin.Non-limiting examples of suitable cyclodextrins used in compositionsinclude gamma cyclodextrin and hydroxypropyl cyclodextrin. Due to theircyclic structure, cyclodextrins can function as a host, for example, toincorporate flavor material and/or active ingredients in the form of aninclusion complex into compositions. Without wishing to be bound totheory, the incorporated flavor and/or active ingredient may be releasedas the result of thermal degradation and/or transfer to saliva once thecomposition is placed in the high moisture, oral cavity of the user. Inone embodiment of the present disclosure, at least a portion of the atleast one active agent is bound to the cyclodextrin. In someembodiments, when a cyclodextrin or similar complexing agent isutilized, it may be beneficial to limit the total moisture content ofthe overall composition or product. Reduced moisture may improve productstability, and it thus can be useful for the total moisture content ofcompositions and products including a cyclodextrin or other complexingagent to be in the range of about 5% to about 30%, about 10% to about30%, or about 15% to about 30% by weight based on the total weight ofthe composition or product.

The aforementioned additives can be employed together (e.g., as additiveformulations) or separately (e.g., individual additive components can beadded at different stages involved in the preparation of the finalmixture). Furthermore, the aforementioned types of additives may beencapsulated as provided in the final product or mixture. Exemplaryencapsulated additives are described, for example, in WO2010/132444 toAtchley, which has been previously incorporated by reference herein.

Particles

In some embodiments, any one or more of a filler component, a tobaccomaterial, and the overall oral product described herein can be describedas a particulate material. As used herein, the term “particulate” refersto a material in the form of a plurality of individual particles, someof which can be in the form of an agglomerate of multiple particles,wherein the particles have an average length to width ratio less than2:1, such as less than 1.5:1, such as about 1:1. In various embodiments,the particles of a particulate material can be described assubstantially spherical or granular.

The particle size of a particulate material may be measured by sieveanalysis. As the skilled person will readily appreciate, sieve analysis(otherwise known as a gradation test) is a method used to measure theparticle size distribution of a particulate material. Typically, sieveanalysis involves a nested column of sieves which comprise screens,preferably in the form of wire mesh cloths. A pre-weighed sample may beintroduced into the top or uppermost sieve in the column, which has thelargest screen openings or mesh size (i.e. the largest pore diameter ofthe sieve). Each lower sieve in the column has progressively smallerscreen openings or mesh sizes than the sieve above. Typically, at thebase of the column of sieves is a receiver portion to collect anyparticles having a particle size smaller than the screen opening size ormesh size of the bottom or lowermost sieve in the column (which has thesmallest screen opening or mesh size).

In some embodiments, the column of sieves may be placed on or in amechanical agitator. The agitator causes the vibration of each of thesieves in the column. The mechanical agitator may be activated for apre-determined period of time in order to ensure that all particles arecollected in the correct sieve. In some embodiments, the column ofsieves is agitated for a period of time from 0.5 minutes to 10 minutes,such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes,such as for approximately 3 minutes. Once the agitation of the sieves inthe column is complete, the material collected on each sieve is weighed.The weight of each sample on each sieve may then be divided by the totalweight in order to obtain a percentage of the mass retained on eachsieve. As the skilled person will readily appreciate, the screen openingsizes or mesh sizes for each sieve in the column used for sieve analysismay be selected based on the granularity or known maximum/minimumparticle sizes of the sample to be analysed. In some embodiments, acolumn of sieves may be used for sieve analysis, wherein the columncomprises from 2 to 20 sieves, such as from 5 to 15 sieves. In someembodiments, a column of sieves may be used for sieve analysis, whereinthe column comprises 10 sieves. In some embodiments, the largest screenopening or mesh sizes of the sieves used for sieve analysis may be 1000μm, such as 500 μm, such as 400 μm, such as 300 μm.

In some embodiments, any particulate material referenced herein (e.g.,filler component, tobacco material, and the overall oral product) can becharacterized as having at least 50% by weight of particles with aparticle size as measured by sieve analysis of no greater than about1000 μm, such as no greater than about 500 μm, such as no greater thanabout 400 μm, such as no greater than about 350 μm, such as no greaterthan about 300 μm. In some embodiments, at least 60% by weight of theparticles of any particulate material referenced herein have a particlesize as measured by sieve analysis of no greater than about 1000 μm,such as no greater than about 500 μm, such as no greater than about 400μm, such as no greater than about 350 μm, such as no greater than about300 μm. In some embodiments, at least 70% by weight of the particles ofany particulate material referenced herein have a particle size asmeasured by sieve analysis of no greater than about 1000 μm, such as nogreater than about 500 μm, such as no greater than about 400 μm, such asno greater than about 350 μm, such as no greater than about 300 μm. Insome embodiments, at least 80% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of no greater than about 1000 μm, such as no greaterthan about 500 μm, such as no greater than about 400 μm, such as nogreater than about 350 μm, such as no greater than about 300 μm. In someembodiments, at least 90% by weight of the particles of any particulatematerial referenced herein have a particle size as measured by sieveanalysis of no greater than about 1000 μm, such as no greater than about500 μm, such as no greater than about 400 μm, such as no greater thanabout 350 μm, such as no greater than about 300 μm. In some embodiments,at least 95% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis ofno greater than about 1000 μm, such as no greater than about 500 μm,such as no greater than about 400 μm, such as no greater than about 350μm, such as no greater than about 300 μm. In some embodiments, at least99% by weight of the particles of any particulate material referencedherein have a particle size as measured by sieve analysis of no greaterthan about 1000 μm, such as no greater than about 500 μm, such as nogreater than about 400 μm, such as no greater than about 350 μm, such asno greater than about 300 μm. In some embodiments, approximately 100% byweight of the particles of any particulate material referenced hereinhave a particle size as measured by sieve analysis of no greater thanabout 1000 μm, such as no greater than about 500 μm, such as no greaterthan about 400 μm, such as no greater than about 350 μm, such as nogreater than about 300 μm.

In some embodiments, at least 50% by weight, such as at least 60% byweight, such as at least 70% by weight, such as at least 80% by weight,such as at least 90% by weight, such as at least 95% by weight, such asat least 99% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis offrom about 0.01 μm to about 1000 μm, such as from about 0.05 μm to about750 μm, such as from about 0.1 μm to about 500 μm, such as from about0.25 μm to about 500 μm. In some embodiments, at least 50% by weight,such as at least 60% by weight, such as at least 70% by weight, such asat least 80% by weight, such as at least 90% by weight, such as at least95% by weight, such as at least 99% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of from about 10 μm to about 400 μm, such as fromabout 50 μm to about 350 μm, such as from about 100 μm to about 350 μm,such as from about 200 μm to about 300 μm.

Preparation

The manner by which the various components of the present compositionsare combined may vary. As such, an overall mixture of various componentswith e.g., powdered mixture components may be relatively uniform innature. The components noted above, which may be in liquid or dry solidform, can be admixed in a pretreatment step prior to mixture with anyremaining components of the mixture, or simply mixed together with allother liquid or dry ingredients. The various components may becontacted, combined, or mixed together using any mixing technique orequipment known in the art. Any mixing method that brings the mixtureingredients into intimate contact can be used, such as a mixingapparatus featuring an impeller or other structure capable of agitation.Examples of mixing equipment include casing drums, conditioningcylinders or drums, liquid spray apparatus, conical-type blenders,ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000and FKM3000 from Littleford Day, Inc., Plough Share types of mixercylinders, Hobart mixers, and the like. See also, for example, the typesof methodologies set forth in U.S. Pat. No. 4,148,325 to Solomon et al.;U.S. Pat. No. 6,510,855 to Korte et al.; and U.S. Pat. No. 6,834,654 toWilliams, each of which is incorporated herein by reference. In someembodiments, the components forming the mixture are prepared such thatthe mixture thereof may be used in a starch molding process for formingthe mixture. Manners and methods for formulating mixtures will beapparent to those skilled in the art. See, for example, the types ofmethodologies set forth in U.S. Pat. No. 4,148,325 to Solomon et al.;U.S. Pat. No. 6,510,855 to Korte et al.; and U.S. Pat. No. 6,834,654 toWilliams, U.S. Pat. No. 4,725,440 to Ridgway et al., and U.S. Pat. No.6,077,524 to Bolder et al., each of which is incorporated herein byreference.

Configured for Oral Use

Provided herein is a product configured for oral use. The term“configured for oral use” as used herein means that the product isprovided in a form such that during use, saliva in the mouth of the usercauses one or more of the components of the mixture (e.g., flavoringagents and/or nicotine) to pass into the mouth of the user. In certainembodiments, the product is adapted to deliver releasable components toa user through mucous membranes in the user's mouth and, in someinstances, said releasable component is an active ingredient (including,but not limited to, for example, nicotine) that can be absorbed throughthe mucous membranes in the mouth when the product is used.

Products configured for oral use as described herein may take variousforms, including gels, pastilles, gums, lozenges, powders, and pouches.Gels can be soft or hard. Certain products configured for oral use arein the form of pastilles. As used herein, the term “pastille” refers toa dissolvable oral product made by solidifying a liquid or gel mixtureso that the final product is a somewhat hardened solid gel. The rigidityof the gel is highly variable. Certain products of the disclosure are inthe form of solids. Certain products can exhibit, for example, one ormore of the following characteristics: crispy, granular, chewy, syrupy,pasty, fluffy, smooth, and/or creamy. In certain embodiments, thedesired textural property can be selected from the group consisting ofadhesiveness, cohesiveness, density, dryness, fracturability,graininess, gumminess, hardness, heaviness, moisture absorption,moisture release, mouthcoating, roughness, slipperiness, smoothness,viscosity, wetness, and combinations thereof.

The products comprising the mixtures of the present disclosure may bedissolvable. As used herein, the terms “dissolve,” “dissolving,” and“dissolvable” refer to mixtures having aqueous-soluble components thatinteract with moisture in the oral cavity and enter into solution,thereby causing gradual consumption of the product. According to oneaspect, the dissolvable product is capable of lasting in the user'smouth for a given period of time until it completely dissolves.Dissolution rates can vary over a wide range, from about 1 minute orless to about 60 minutes. For example, fast release mixtures typicallydissolve and/or release the active substance in about 2 minutes or less,often about 1 minute or less (e.g., about 50 seconds or less, about 40seconds or less, about 30 seconds or less, or about 20 seconds or less).Dissolution can occur by any means, such as melting, mechanicaldisruption (e.g., chewing), enzymatic or other chemical degradation, orby disruption of the interaction between the components of the mixture.In some embodiments, the product can be meltable as discussed, forexample, in U.S. patent app. Pub. No. 2012/0037175 to Cantrell et al. Inother embodiments, the products do not dissolve during the product'sresidence in the user's mouth.

In one embodiment, the product comprising the composition of the presentdisclosure is in the form of a mixture disposed within amoisture-permeable container (e.g., a water-permeable pouch). Suchmixtures in the water-permeable pouch format are typically used byplacing one pouch containing the mixture in the mouth of a humansubject/user. Generally, the pouch is placed somewhere in the oralcavity of the user, for example under the lips, in the same way as moistsnuff products are generally used. The pouch preferably is not chewed orswallowed. Exposure to saliva then causes some of the components of themixture therein (e.g., flavoring agents and/or active ingredients, suchas nicotine) to pass through e.g., the water-permeable pouch and providethe user with flavor and satisfaction, and the user is not required tospit out any portion of the mixture. After about 10 minutes to about 60minutes, typically about 15 minutes to about 45 minutes, ofuse/enjoyment, substantial amounts of the mixture have been ingested bythe human subject, and the pouch may be removed from the mouth of thehuman subject for disposal.

Accordingly, in certain embodiments, the mixture as disclosed herein andany other components noted above are combined within amoisture-permeable packet or pouch that acts as a container for use ofthe mixture to provide a pouched product configured for oral use.Certain embodiments of the disclosure will be described with referenceto the FIGURE, and these described embodiments involve snus-typeproducts having an outer pouch and containing a mixture as describedherein. As explained in greater detail below, such embodiments areprovided by way of example only, and the pouched products of the presentdisclosure can include the composition in other forms. Themixture/construction of such packets or pouches, such as the containerpouch 102 in the embodiment illustrated in the FIGURE, may be varied.Referring to the FIGURE, there is shown a first embodiment of a pouchedproduct 100. The pouched product 100 includes a moisture-permeablecontainer in the form of a pouch 102, which contains a material 104comprising a composition as described herein. The pouched product 100may be an example of a product as described herein formed at least inpart from the described compositions.

Suitable packets, pouches or containers of the type used for themanufacture of smokeless tobacco products are available under thetradenames CatchDry, Ettan, General, Granit, Goteborgs Rape, GrovsnusWhite, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen,Kicks, Probe, Prince, Skruf and TreAnkrare. The mixture may be containedin pouches and packaged, in a manner and using the types of componentsused for the manufacture of conventional snus types of products. Thepouch provides a liquid-permeable container of a type that may beconsidered to be similar in character to the mesh-like type of materialthat is used for the construction of a tea bag. Components of themixture readily diffuse through the pouch and into the mouth of theuser.

Non-limiting examples of suitable types of pouches are set forth in, forexample, U.S. Pat. No. 5,167,244 to Kjerstad and U.S. Pat. No. 8,931,493to Sebastian et al.; as well as U.S. patent app. Pub. Nos. 2016/0000140to Sebastian et al.; 2016/0073689 to Sebastian et al.; 2016/0157515 toChapman et al.; and 2016/0192703 to Sebastian et al., each of which areincorporated herein by reference. Pouches can be provided as individualpouches, or a plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or30 pouches) can be connected or linked together (e.g., in an end-to-endmanner) such that a single pouch or individual portion can be readilyremoved for use from a one-piece strand or matrix of pouches.

An example pouch may be manufactured from materials, and in such amanner, such that during use by the user, the pouch undergoes acontrolled dispersion or dissolution. Such pouch materials may have theform of a mesh, screen, perforated paper, permeable fabric, or the like.For example, pouch material manufactured from a mesh-like form of ricepaper, or perforated rice paper, may dissolve in the mouth of the user.As a result, the pouch and mixture each may undergo complete dispersionwithin the mouth of the user during normal conditions of use, and hencethe pouch and mixture both may be ingested by the user. Other examplesof pouch materials may be manufactured using water dispersible filmforming materials (e.g., binding agents such as alginates,carboxymethylcellulose, xanthan gum, pullulan, and the like), as well asthose materials in combination with materials such as ground cellulosics(e.g., fine particle size wood pulp). Preferred pouch materials, thoughwater dispersible or dissolvable, may be designed and manufactured suchthat under conditions of normal use, a significant amount of the mixturecontents permeate through the pouch material prior to the time that thepouch undergoes loss of its physical integrity. If desired, flavoringingredients, disintegration aids, and other desired components, may beincorporated within, or applied to, the pouch material.

The amount of material contained within each product unit, for example,a pouch, may vary. In some embodiments, the weight of the mixture withineach pouch is at least about 50 mg, for example, from about 50 mg toabout 2 grams, from about 100 mg to about 1.5 g, or from about 200 toabout 700 mg. In some smaller embodiments, the weight of the mixturewithin each pouch may be from about 100 to about 300 mg. For a largerembodiment, the weight of the material within each pouch may be fromabout 300 mg to about 700 mg. If desired, other components can becontained within each pouch. For example, at least one flavored strip,piece or sheet of flavored water dispersible or water soluble material(e.g., a breath-freshening edible film type of material) may be disposedwithin each pouch along with or without at least one capsule. Suchstrips or sheets may be folded or crumpled in order to be readilyincorporated within the pouch. See, for example, the types of materialsand technologies set forth in U.S. Pat. No. 6,887,307 to Scott et al.and U.S. Pat. No. 6,923,981 to Leung et al.; and The EFSA Journal (2004)85, 1-32; which are incorporated herein by reference.

A pouched product as described herein can be packaged within anysuitable inner packaging material and/or outer container. See also, forexample, the various types of containers for smokeless types of productsthat are set forth in U.S. Pat. No. 7,014,039 to Henson et al.; U.S.Pat. No. 7,537,110 to Kutsch et al.; U.S. Pat. No. 7,584,843 to Kutschet al.; U.S. Pat. No. 8,397,945 to Gelardi et al., D592,956 toThiellier; D594,154 to Patel et al.; and D625,178 to Bailey et al.; U.S.Pat. Pub. Nos. 2008/0173317 to Robinson et al.; 2009/0014343 to Clark etal.; 2009/0014450 to Bjorkholm; 2009/0250360 to Bellamah et al.;2009/0266837 to Gelardi et al.; 2009/0223989 to Gelardi; 2009/0230003 toThiellier; 2010/0084424 to Gelardi; and 2010/0133140 to Bailey et al;2010/0264157 to Bailey et al.; and 2011/0168712 to Bailey et al. whichare incorporated herein by reference.

Compositions and products according to the present disclosure may beadapted to or configured to provide a desired release profile inrelation to one or more of the releasable materials provided therewith.In some embodiments, a desired release rate may particularly relate to aflavor material. In other embodiments, a desired release rate mayparticularly relate to an active agent.

Many modifications and other embodiments of the invention will come tomind to one skilled in the art to which this invention pertains havingthe benefit of the teachings presented in the foregoing description.Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

1. An oral composition comprising: at least one active agent; at leastone filler component; and water in an amount sufficient such that theoral composition has a total moisture content of about 15% to about 30%by weight or greater based on the total weight of the oral composition.2. The oral composition of claim 1, wherein at least a portion of the atleast one active agent is bound to at least a portion of the at leastone filler component.
 3. The oral composition of claim 1, wherein theoral composition further comprises a binding agent.
 4. The oralcomposition of claim 3, wherein the binding agent is selected from agroup consisting of povidone, sodium alginate, starch-based binders,pectin, carrageenan, pullulan, zein, gum, and combinations thereof. 5.The oral composition of claim 1, wherein the at least one active agentis selected from a group consisting of botanicals, stimulants, aminoacids, vitamins, cannabinoids, cannabimimetics, terpenes,nutraceuticals, and combinations thereof.
 6. The oral composition ofclaim 1, wherein the at least one active agent is a nicotine component.7. The oral composition of claim 6, wherein the nicotine component isone or both of nicotine free base and a nicotine salt.
 8. The oralcomposition of claim 6, wherein the nicotine component is present in anamount such that a weight to weight ratio of the nicotine component tothe total moisture content is about 0.01 to about 0.2.
 9. The oralcomposition of claim 6, wherein the nicotine component is present in anamount such that a weight to weight ratio of the nicotine component tothe total moisture content is about 0.01 to about 0.1.
 10. The oralcomposition of claim 6, wherein the nicotine component is present in anamount such that a weight to weight ratio of the nicotine component tothe total moisture content is about 0.03 to about 0.08.
 11. The oralcomposition of claim 6, wherein the nicotine component is present in anamount of greater than 2% by weight based on the total weight of theoral composition.
 12. The oral composition of claim 11, wherein thenicotine component is present in an amount of about 3% to about 10% byweight based on the total weight of the oral composition.
 13. The oralcomposition of claim 11, wherein the water is present in an amount suchthat the oral composition has a total moisture content of greater than20% by weight based on the total weight of the oral composition.
 14. Theoral composition of claim 13, wherein the water is present in an amountsuch that oral composition has a total moisture content of about 20% toabout 45% by weight based on the total weight of the oral composition.15. The oral composition of claim 11, wherein the oral composition issubstantially or completely free of tobacco.
 16. The oral composition ofclaim 11, wherein the oral composition has a pH that is greater than 7.17. The oral composition of claim 6, wherein the nicotine component ispresent in an amount of less than 1% by weight based on the total weightof the oral composition.
 18. The oral composition of claim 17, whereinthe nicotine component is present in an amount of about 0.010% to about0.9% by weight based on the total weight of the oral composition. 19.The oral composition of claim 17, wherein the water is present in anamount such that oral composition has a total moisture content of about15% to about 30% by weight based on the total weight of the oralcomposition.
 20. The oral composition of claim 1, wherein the oralcomposition further comprises a cyclodextrin. 21.-25. (canceled)